Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus

Sponsor
AstraZeneca
Study ID
NCT01294423
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
  • Dapagliflozin — DRUG
    Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
  • Placebo — DRUG
    Matching placebo for Dapagliflozin 5mg/10mg oral dose

Study Details

This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.

Key Dates

Start date
Feb 28, 2011
Status verified
Jul 2014
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

Enrollment
261 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Dapagliflozin 5 mg
  • Experimental: 2
    Dapagliflozin 10 mg
  • Placebo Comparator: 3

Primary Outcome Measure

Adjusted Mean Change in HbA1c Levels [ Time Frame: From Baseline to Week 24 ]

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